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13-Cis retinoic acid in combination with interferon-alpha and concomitant irradiation in squamous cell carcinomas: Toxicity and feasibility


, : 13-Cis retinoic acid in combination with interferon-alpha and concomitant irradiation in squamous cell carcinomas: Toxicity and feasibility. Onkologie 18(6): 568-572

Background: A solid body of preclinical and clinical data supports the novel regimen of combined 13-cis retinoic acid (13-cis RA) and interferon-alpha (IFN-alpha) in various human malignancies especially in squamous cell carcinomas. The toxicity and feasibility of such a combined treatment together with simultaneous radiotherapy has not yet been prospectively evaluated. Material and Method: A total of 18 patients entered this pilot study. 9 female and 9 male patients with a mean age of 53 years were treated. Tumor types were 7 times cervical cancer, 4 times head and neck cancer, 6 times lung cancer, and 1 times esophageal cancer. Treatment schedule consisted of RA (0.5-1.0 mg/kg body weight p.o. daily), IFN-alpha (3.0 million IU s.c. 3 times /week or 3.0 million IU s.c./daily), and concomitant irradiation (50-70 Gy in 1.8-2.0 daily fractions, in 5-7 weeks). Systemic treatment was administered for a total of 12 weeks. Results: Except for one case with major lung toxicity due to pneumonitis, toxicity was mild to moderate and did not exceed toxicity seen under radiation therapy alone. The most frequent side effects observed were anemia and leucopenia, mucositis, cheilitis, fever, nausea and diarrhea. Conclusion: Since the combination of RA and IFN-alpha has proven to be effective in advanced squamous cell carcinoma and since the addition of ionizing radiation has both a preclinical and clinical rationale we conclude that such a kind of treatment is feasible and suggest further evaluation of this combination in phase I/II trials.

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